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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 14 days oral exposure
Deviations:
not specified
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
No data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: water
Duration of treatment / exposure:
14 days
Frequency of treatment:
daily
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:94 mg/kg bwBasis:nominal in diet
Remarks:
Doses / Concentrations:187 mg/kg bwBasis:nominal in diet
Remarks:
Doses / Concentrations:375 mg/kg bwBasis:nominal in diet
Remarks:
Doses / Concentrations:750 mg/kg bwBasis:nominal in diet
Remarks:
Doses / Concentrations:1500 mg/kg bwBasis:nominal in diet
No. of animals per sex per dose:
5 male and 5 females for each concentration
Control animals:
yes, concurrent no treatment

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
No mortality and no clinical signs were observed.
Mortality:
mortality observed, treatment-related
Description (incidence):
No mortality and no clinical signs were observed.
Haematological findings:
effects observed, treatment-related
Description (incidence and severity):
see "details on results"
Gross pathological findings:
effects observed, treatment-related
Description (incidence and severity):
see "details on results"
Details on results:
One female rat that received 1,500 mg/kg died on day 16 just before the terminal kill (Table 8). All other rats survived to the end of the studies. Final mean body weights of males and females were not adversely affected by C.I. Acid Orange 3. Orange urine or extremities were observed for rats that received 750 or 1,500 mg/kg, 3/5 males and 4/5 females that received 375 mg/kg, 2/5 females that received 187 mg/kg, and 115 females that received 94 mg/kg. ~o compound-related effects were observed at necropsy.

Effect levels

Dose descriptor:
NOAEL
Effect level:
1 500 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
mortality

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The value of NOAEL for repeated dose toxicity was established at 1500 mg/kg bw/day.
Executive summary:

The value of NOAEL for repeated dose toxicity was established at 1500 mg/kg bw/day.